|Flamel Technologies Doses First Patient in REST-ON Phase III Trial of FT218 for Excessive Daytime Sleepiness & Cataplexy|
MarketwiredDecember 16, 2016
LYON, FRANCE--(Marketwired - Dec 16, 2016) - Flamel Technologies SA ( NASDAQ : FLML ) today announced that the first patient has been dosed in its Rest-On Phase III clinical trial of FT218, a once-nightly formulation of sodium oxybate utilizing the Company's proprietary Micropump® technology, for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy.
Mike Anderson, Flamel's Chief Executive Officer, remarked, "This is an exciting milestone for Flamel. FT218 is our most important asset and has the potential to provide a number of benefits to narcoleptic patients, who suffer from debilitating quality of life issues. We are seeing significant interest in this trial from both physicians and patients alike, and are excited to continue the screening and enrollment process as more sites are initiated throughout Europe, Canada and the U.S."
REST-ON is a 264 patient, double-blind, randomized, placebo controlled Phase III clinical trial to assess the efficacy and safety of a once nightly formulation of sodium oxybate for extended-release oral suspension for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The study will be conducted across 50 -- 60 clinical sites throughout the U.S., Europe and Canada.
About Sodium Oxybate
Sodium Oxybate is the sodium salt of gamma hydroxybutyrate, an endogenous compound and metabolite of the neurotransmitter gamma-aminobutyric acid (GABA). It has been described as a therapeutic agent with high medical value; in Europe and the United States it is currently approved in a twice nightly formulation indicated for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy at doses up to 9g/night.
Micropump® is a microparticulate system that allows the development of modified and/or controlled release of solid, oral dosage formulations of drugs. Micropump allows the achievement of extremely precise pharmacokinetic profiles of single or combination of drugs, in a variety of formats (such as tablets, capsules, sachet, or liquids (LiquiTime®), while preserving the targeted release rate over the shelf-life of the product.
About Flamel Technologies
Flamel Technologies SA ( NASDAQ : FLML ) is a specialty pharmaceutical company utilizing its core competencies in formulation development and drug delivery to develop safer and more efficacious pharmaceutical products, addressing unmet medical needs and/or reducing overall healthcare costs